I want to understand all the requirements of EU MDR and their conciliation with ISO 13485 and FDA 21 CFR
Clean room criteria for ISO 13485
I have a 20 x 30 glass walled clean room sitting in a create for some time now and have decided to erect it so we can finally start working at an ISO 13485 situation. I would like to know for now only clean room criteria for iso 1 (class A) and based on that, I would like to know costs to retain you or cost to provide a cert jhow to go about getting an inspection etc
Question about notify body
I am putting an ISO 13485 QMS system. I have previously had 2 QMS systems in other companies accredited by notified bodies and thought that this is the only way to gain certification.
My present line Manager states other companies other than notified bodies can issue ISO 13485 instead of going down the notified body route, I am not sure that this is right. I cannot find a company that does this.
Am I right in thinking it has to be a notified body
What sections of ISO 13485 cover computer systems?
Would like to know what sections of ISO-13485 cover computer systems or is it another standard?
Auditing according to section 8.2.2
I've been asked to conduct a 13485 audit specific to complaint handling. Would I only need to audit according to section 8.2.2? Thank you!
IEC 62366-1 question
Hi Kristina – is this standard only applicable to medical devices with computer/software components?
If so, is there a different usability standard that pertains to non-computer related medical devices ?
Guidance for dealing with "old" devices
We have been marketing our devices in the EU since 2011 and have records and survaillance of these Class I devices since that time. These devices are cleansing devices for the eyelid, eyelashes and area around the eye but not for the eye itself. We also market a device called *** whose active ingredient is Tea Tree Oil in very low quantity or percent concentration. According to the guidance for Legacy devices MDCG 2021-25 issed October 2021, these devices are not considered "New' devices (devices to be submitted under the MDR and new to the EU market) nor or they considered " Legacy" devices (devices who were introduced to the market during the development of the MDR but before May 26, 2021. Our devices according to this guidance are considered "OLD" devices and defined as those devices that were placed on the market before 26 May 2021 in accordance with the AIMDD or the MDD or in accordance with the applicable rules before the directive had entered into force. . Is there a guidance for these "old" devices.
We are preparing our "Technical Documentation" documents for Class I products.
Our partner company provide us the attached GSPR form which should be filled out for each product.
But I did not find such form in the documents I purchased from you. I guess, we have a new document instead.
Can you please let me know which document should be used as GSPR for Class I products?
Hi we are a new medical device manufacturer, preparing for our MDR submission. For our samples, do the sample need to be like how it would be i.e. with design, brand name, labels, product description with translation of different languages, and EC Rep?
Classification of medical devices
I have a question which is bothering me regarding the classification of medical devices, and what would be regarded as a medical device. I have a client who assembles and sells X-Ray systems. All the parts, apart from some of the mechanical parts are imported from various suppliers and assembled into a single system here in South Africa. The mechanical parts (X-Ray table, Bucky stand and tube stand) are manufactured locally. Are they to be regarded as medical devices in themselves, or are they only components of the completed system? I am thinking that the X-Ray table has no medical device function before it is assembled into a X-Ray system. The same applies to locally built trailers which are used to install occupational health system and X-Ray systems into which are used as mobile units, especially in rural areas, Surely the trailer is not a medical device.
My thinking is that the mechanical components do not need a separate medical device file, but can be included as component parts in the X-Ray system medical device file. Or am I seeing this completely wrong?